Preliminary discussion on the appendix and inspection memorandum of investigational medicinal products of PIC/S
10.13699/j.cnki.1001-6821.2024.15.032
- VernacularTitle:PIC/S临床试验用药品附录及检查备忘录的初步探讨
- Author:
De LU
1
;
Jing-Feng HU
;
Wen-Yan XU
;
Yu-Sheng PEI
;
Xiao YE
Author Information
1. 国家药品监督管理局药品审评检查长三角分中心,上海 201203
- Keywords:
investigational medicinal product;
good manufacturing practice;
Pharmaceutical Inspection Co-operation Scheme;
drug inspection
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(15):2301-2304
- CountryChina
- Language:Chinese
-
Abstract:
The National Medical Products Administration have become an official applicant of the Pharmaceutical Inspection Co-operation Scheme(PIC/S)in 2023,and the good manufacturing practice appendix and inspection memorandum are key documents of PIC/S.Based on the analysis of the history,framework and main contents of the appendix and inspection memorandum of PIC/S investigational medicinal products,this paper discusses the key contents of the appendix and inspection memorandum of PIC/S clinical trial drugs,and provides reference for the inspection work.
